Celltrion’s ‘Psoriasis’ Biosimilar Poised to Challenge Big Pharma with Phase 1 Data

On September 17, the 34th European Academy of Dermatology and Venereology (EADV) conference kicked off in Paris, France, drawing more than 16,000 attendees from over 120 countries. The event featured global biopharmaceutical companies, including big pharma, presenting their latest clinical findings through e-poster displays.

Celltrion, making its second consecutive appearance with a standalone booth at EADV, unveiled a comparative study of its biosimilar secukinumab (CT-P55) against the original drug. Conducted on healthy adult males, the study examined pharmacokinetics, safety, and immunogenicity, marking the first public disclosure of CT-P55’s equivalence to Cosentyx in terms of drug exposure (AUC, Cmax), safety, and immunogenicity.

Industry insiders, including representatives from major pharmaceutical companies, were observed scrutinizing various clinical results, with particular attention given to Celltrion’s presentation.

Celltrion’s poster addressed a critical question in biosimilar development: does the new drug match the original in terms of body distribution and safety profile?

The study design involved administering a single 150 mg subcutaneous injection to healthy volunteers, followed by a 22-week monitoring period. Participants were randomly assigned in equal proportions to receive either CT-P55, the European Union (EU)-approved product, or the U.S.-approved product (both secukinumab).

Researchers primarily assessed AUC0-inf (total drug exposure over time) and Cmax (peak serum concentration), thereby confirming biological equivalence across these key parameters.

Celltrion reported that CT-P55 demonstrated a safety profile comparable to the original product. This trifecta of pharmacokinetic, safety, and immunogenicity equivalence signals a promising start for the biosimilar.

These phase 1 findings pave the way for the ongoing phase 3 trial involving 375 patients with moderate to severe plaque psoriasis. CT-P55 has already secured European Investigational New Drug (IND) approval for this advanced stage of clinical testing.

Building on its successful European market presence in autoimmune and oncology treatments, Celltrion aims to bolster its position by expanding into dermatological therapies.

In a related development, Celltrion is set to host a symposium at EADV on September 18 for healthcare professionals. Titled, The Use and Understanding of Biosimilars in Chronic Spontaneous Urticaria, the event will showcase the company’s dermatological portfolio, including Omni Lok (omalizumab) for chronic spontaneous urticaria (CSU).

The symposium will feature presentations by leading European experts, who will discuss 40-week clinical data from Omni Lok’s global phase 3 trial, including post-treatment follow-ups, and will explore the competitive landscape for biosimilars in dermatology.